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- US-Register für klinische Studien
- Klinische Studie NCT02875522
The Effects of Aerobic Exercise Training on Vascular, Cardiac and Cerebral Vascular Function in COPD
17. August 2016 aktualisiert von: University of British Columbia
The Effects of Aerobic Exercise Training on Peripheral Vascular, Cardiac and Cerebral Vascular Function in Patients With Chronic Obstructive Pulmonary Disease
The primary cause of chronic obstructive pulmonary disease is smoking, which can lead to inflammation in the lungs and blood vessels that can lead to secondary problems such as blood vessel disease, high blood pressure and heart disease.
Aerobic exercise training has been shown to reduce the risk of heart and brain disease; however, it is currently unknown whether exercise training can have the same affect in patients with COPD.
The aim of this study is to investigate how eight weeks of aerobic exercise training improves blood vessel and heart function and brain blood flow in patients with COPD.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Chronic obstructive pulmonary disease (COPD) is a treatable respiratory condition that is only partially reversible.
The primary cause of COPD is smoking which leads to airway inflammation and oxidative damage to the lungs, which has been linked to the development and progression of the disease.
The inflammation is not isolated to the lungs as patients with COPD also have systemic inflammation that has been linked to a number of cardiovascular comorbidities such as endothelial dysfunction, cardiovascular disease and stroke.
Evidence demonstrates that COPD patients have a greater incidence of vascular dysfunction and adverse vascular remodeling, which worsens with disease severity.
In fact, patients with COPD are at 35 times greater risk of developing cardiovascular disease and stroke than healthy aged matched individuals.
In healthy individuals and a number of chronic conditions, aerobic exercise training is well established to reduce the risk of cardiovascular and cerebrovascular disease.
The benefits of exercise are likely through improvements in endothelial function, systemic inflammation, and cardiac and cerebral vascular function.
However, whether exercise training can have the same effects in a chronic inflammatory condition like COPD has not been studied.
The purpose of this study is to determine the effectiveness of an 8 week aerobic exercise training program in patient's chronic obstructive pulmonary disease as determined by improvements in endothelial function, systemic inflammation and cardiac and cerebral vascular function.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
58
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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-
British Columbia
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Kelowna, British Columbia, Kanada, V1V 1V7
- University of British Columbia
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
40 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Non-smokers (>6 months);
- Forced expiratory volume in one second/ forced vital capacity (FEV1/FVC) < 0.7 and FEV1/FVC <lower limit of normal
- Stable (>3 months exacerbation free)
Exclusion Criteria:
- On supplemental oxygen;
- Known cardiac or cerebral vascular disease, diabetes, obstructive sleep apnea;
- Uncontrolled hypertension;
- BMI >30kg/m2
- Currently performing pulmonary rehabilitation or structured exercise training;
- Desaturate during exercise (SpO2<85%)
- Cardiovascular contraindications to exercise in the incremental test used for screening
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Patients with COPD
Stable patients with COPD participated in an 8-week (24 session) individualized, non-linear aerobic exercise training program consisting of upper and lower body cycle ergometry.
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Aerobic exercise performed on lower body stationary ergometer and an upper extremity arm crank.
Intensity (50-95% workload maximum) and durations (20-45 min) are fluctuated daily to optimize training stress and adaptation
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Aktiver Komparator: Healthy Controls
Age, sex, BMI and activity matched controls participated in an 8-week (24 session) individualized, non-linear aerobic exercise training program consisting of upper and lower body cycle ergometry.
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Aerobic exercise performed on lower body stationary ergometer and an upper extremity arm crank.
Intensity (50-95% workload maximum) and durations (20-45 min) are fluctuated daily to optimize training stress and adaptation
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Endothelial Function
Zeitfenster: 8-weeks (following 24 sessions of exercise training)
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The change in brachial artery flow mediated dilation measured using reactive hyperaemia
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8-weeks (following 24 sessions of exercise training)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Arterial Stiffness
Zeitfenster: 8-weeks (following 24 sessions of exercise training)
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The change in pulse wave velocity measured using tonometry
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8-weeks (following 24 sessions of exercise training)
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Carotid intima-medial thickness
Zeitfenster: 8-weeks (following 24 sessions of exercise training)
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The change in carotid intima-medial thickness measured by ultrasound
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8-weeks (following 24 sessions of exercise training)
|
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Carotid Compliance
Zeitfenster: 8-weeks (following 24 sessions of exercise training)
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The change in carotid compliance measured using tonometry and ultrasound for the carotid arteries
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8-weeks (following 24 sessions of exercise training)
|
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Inflammatory Biomarkers
Zeitfenster: 8-weeks (following 24 sessions of exercise training)
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The change in serum levels of CRP, IL-6, IL-10 and TNF-alpha measured using Luminex multiplex bead-based technology
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8-weeks (following 24 sessions of exercise training)
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Systolic function
Zeitfenster: 8-weeks (following 24 sessions of exercise training)
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The change in stroke volume using echocardiography
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8-weeks (following 24 sessions of exercise training)
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Diastolic function
Zeitfenster: 8-weeks (following 24 sessions of exercise training)
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The change in left ventricular end-diastolic volume using echocardiography
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8-weeks (following 24 sessions of exercise training)
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Cerebral Blood Flow
Zeitfenster: 8-weeks (following 24 sessions of exercise training)
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The change in cerebral and neck blood flow using ultrasound
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8-weeks (following 24 sessions of exercise training)
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Cerebrovascular Reactivity
Zeitfenster: 8-weeks (following 24 sessions of exercise training)
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The change in middle cerebral artery velocity in response to carbon dioxide
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8-weeks (following 24 sessions of exercise training)
|
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Cerebrovascular Autoregulation
Zeitfenster: 8-weeks (following 24 sessions of exercise training)
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The change in phase delay measured by transfer function analysis
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8-weeks (following 24 sessions of exercise training)
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Neil Eves, PhD, University of British Columbia
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Gelinas JC, Lewis NC, Harper MI, Ainslie PN, Rolf JD, Eves ND. Aerobic Exercise Training on Peripheral Vascular Structure and Function in Patients with Chronic Obstructive Pulmonary Disease. American Journal of Respiratory and Critical Care Medicine, 191:A5305, 2015.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Januar 2012
Primärer Abschluss (Tatsächlich)
1. Mai 2015
Studienabschluss (Tatsächlich)
1. Mai 2015
Studienanmeldedaten
Zuerst eingereicht
4. August 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
17. August 2016
Zuerst gepostet (Schätzen)
23. August 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
23. August 2016
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
17. August 2016
Zuletzt verifiziert
1. August 2016
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- H11-02770
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